Agenda item 7 UNAIDS/PCB (43)/18.27 UPDATE ON THE ACCESS COMPONENTS OF THE UNAIDS 2016-2021 STRATEGY: REMOVING ACCESS BARRIERS TO HEALTH TECHNOLOGIES FOR HIV AND ITS CO-INFECTIONS AND CO-MORBIDITIES IN LOW- AND MIDDLE-INCOME COUNTRIES 11-13 December 2018 | Geneva, Switzerland UNAIDS Programme Coordinating Board Issue date: 19 November 2018 UNAIDS/PCB (43)/18.27 Page 2/34 Additional documents for this item: None Action required at this meeting––the Programme Coordinating Board is invited to: 1. Recall the commitments at previous Programme Coordinating Board meetings and relevant paragraphs from Resolution 70/266 of the UN General Assembly – Political Declaration on HIV and AIDS: On the Fast Track to Accelerating the Fight against HIV and to Ending the AIDS Epidemic by 2030, June 2016: which recognized that access to safe, effective and affordable medicines and commodities for all, without discrimination, in the context of epidemics such as AIDS is fundamental to the full realization of the right of everyone to enjoy the highest attainable standard of physical and mental health. 2. Take note of the findings in the report. 3. Request UNAIDS to: a. Develop a programme of work, through 2021, for the implementation and monitoring of the relevant recommendations in this report and to fully maximize existing and new financial and human resources that can promote access to affordable technologies for all, and ensuring sufficient technical and financial resources to implement such programme of work; b. Engage in advocacy and support, where relevant, to countries, multilateral organizations, the private sector and civil society to collectively ensure innovation and continued access to medicines that meet the needs of all people living with HIV and to prevent transmission of HIV; c. Provide support to low- and middle-income countries to take all necessary steps to address current and future challenges to ensure quality-assured, safe and affordable HIV-related medicines and other health technologies; d. Convene on a regular basis, key actors and stakeholders across the HIV response to discuss and address critical challenges and opportunities related to ensuring innovation and access to medicines and other health technologies for HIV; e. Report the progress in the implementation of these decision points to the Programme Coordinating Board no later than the December 2021 Board Meeting. Cost implications: None UNAIDS/PCB (43)/18.27 Page 3/34 ACRONYMS AIDS acquired immune deficiency syndrome ARV antiretroviral ART antiretroviral therapy FTC emtricitabine Global Fund Global Fund to fight AIDS, Tuberculosis and Malaria HCV hepatitis C virus HIV human immunodeficiency virus IP intellectual property MDG Millennium Development Goal MPP Medicines Patent Pool MSF Médecins Sans Frontières NGO nongovernmental organization PAHO Pan American Health Organization PCB Programme Coordinating Board PEPFAR President’s Emergency Plan for AIDS Relief PrEP pre-exposure prophylaxis R&D research and development SDG Sustainable Development Goal TB tuberculosis TDF tenofovir disoproxil fumarate TRIPS trade-related aspects of intellectual property rights Agreement UNAIDS Joint United Nations Programme on HIV/AIDS UNDP United Nations Development Programme UN United Nations US United States (of America) WHO World Health Organization UNAIDS/PCB (43)/18.27 Page 4/34 TABLE OF CONTENTS EXECUTIVE SUMMARY ................................................................................................................. 5 INTRODUCTION ........................................................................................................................... 8 INITIATIVES, LEGAL AND POLICY TOOLS AND BEST PRACTICES TO OVERCOME ACCESS BARRIERS ... 9 ACCESS TO MEDICINES IN THE 2016–2021 UNAIDS STRATEGY: OVERVIEW, PROGRESS AND CHALLENGES .............................................................................................................................. 10 Assessment of UNAIDS Secretariat contribution to the implementation of UNAIDS Strategy ........ 10 DATA TO MEASURE, EVALUATE AND ACT UPON ACCESS-RELATED BARRIERS ............................... 12 Identified data gaps .......................................................................................................................... 12 CASE STUDIES OF KEY MEDICINES AND OVERVIEW OF OTHER HIV-RELATED TECHNOLOGIES ........ 14 Dolutegravir ...................................................................................................................................... 14 Sofosbuvir ......................................................................................................................................... 15 Bedaquiline ....................................................................................................................................... 16 Pre-exposure prophylaxis ................................................................................................................. 17 ADDITIONAL INFORMATION CONCERNING TECHNOLOGIES TO ADDRESS HIV, OPPORTUNISTIC INFECTIONS AND COINFECTIONS ................................................................................................ 18 HIV medicines for children ................................................................................................................ 18 Vaccines ............................................................................................................................................ 19 HIV pipeline products........................................................................................................................ 19 KEY LESSONS LEARNED FROM CASE STUDIES, INTERVIEWS AND DESK REVIEW ............................ 21 OPPORTUNITIES AND RISKS IN THE POLICY ENVIRONMENT ......................................................... 24 Opportunities in the policy environment ......................................................................................... 24 RECOMMENDATIONS REGARDING UNAIDS’ ROLE IN ENSURING ACCESS TO MEDICINES .............. 25 ANNEX 1: KEY INFORMANT INTERVIEWEES ................................................................................. 29 REFERENCES .............................................................................................................................. 30 UNAIDS/PCB (43)/18.27 Page 5/34 EXECUTIVE SUMMARY 1. Improving access to affordable and effective antiretroviral treatment and reducing AIDS-related deaths has been at the heart of UNAIDS’ mandate. UNAIDS has played a critical leadership role advocating for universal access to HIV treatment, including registration of key antiretroviral medicines (ARVs), development of paediatric formulations, and the full use of safeguards and flexibilities included in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). 2. UNAIDS should intensify efforts to promote access to affordable medicines across low- and middle-income countries, in accordance with its mandate. UNAIDS can: • utilize its convening authority to maintain an open and positive dialogue between diverse stakeholders on issues related to innovation and access to medicines; • promote capacity building for national governments to address threats and opportunities or to itself engage in advocacy where needed; • act as a strong voice on the particular opportunities, best practices, concerns and challenges related to access to paediatric and adult ARVs and other HIV-related health technologies; and • maintain expertise on new developments and provide such information to its partners, government counterparts and civil society. 3. While data and analysis of HIV-related technologies are superior compared to other therapeutic areas, there are multiple gaps. They include: • pricing data for upper-middle-income countries; • registration data across low- and middle-income countries; • information on the availability and suppliers of ARVs; • comprehensive data on medicines to treat opportunistic infections, paediatric HIV, coinfections and comorbidities, and diagnostics; • patent analyses for low- and middle-income countries; and • real-time market data that can provide rapid information on uptake and use of priority products. UNAIDS has an important role in collecting data, convening stakeholders for joint analysis and encouraging collaboration to improve data collection. 4. Advocacy and mobilization are essential for overcoming barriers to affordable and appropriate health technologies. Advocacy can ensure that political barriers, a lack of political will or countervailing commercial considerations are overcome. 5. Nongovernmental organizations (NGOs) and treatment advocates are losing resources, capacity and space to advocate for access to affordable health technologies. NGOs, advocates and activists are central to many of the advances that have improved access to medicines. However, the resources, technical capacity building and opportunities that enable them to promote the most effective responses to AIDS are diminishing. Without the leadership of civil society and treatment advocates, it will not be possible to meet the needs of populations who are denied access to treatment due to political, institutional or economic considerations. 6. Local production of medicines is increasing in countries outside of India. An estimated 80% of all ARVs used to treat people living with HIV are manufactured in India. Additionally, new producers of ARVs and other medicines are emerging elsewhere, including in Algeria, Bangladesh, Brazil, China,